What Is Nilutamide (Nilandron®)?

Reviewed by: HU Medical Review Board | Last reviewed: July 2022

Nilandron® (nilutamide) is an androgen receptor inhibitor, also called an antiandrogen or a nonsteroidal antiandrogen (NSAA), used in combination with surgical castration (removal of the testicles). It is indicated for use in combination with surgical castration in individuals with metastatic prostate cancer (prostate cancer that has spread to another part of the body). Nilutamide is an orally administered medication that comes in tablet form. Individuals taking Nilutamide should also be monitored for changes in liver functioning as well as for signs of interstitial pneumonitis (also known as interstitial lung disease).

How does nilutamide work?

Nilutamide’s active ingredient binds to the androgen receptors in the body. Nilutamide blocks testosterone and other androgens from activating these receptors. Prostate cancer tumors are often fueled to grow by androgens, including testosterone. Turning off the body’s ability to respond to testosterone can potentially halt tumor growth. In addition, nilutamide can be used during early stages of other hormone therapies, such as treatment with Gonadotropin-Releasing Hormone (GnRH) agonists, in order to block the initial surge of testosterone, called tumor flare, that can come along with these medications. The surge of testosterone at the beginning of some of these treatment methods can contribute to rapid tumor growth before it is halted, potentially leading to life-threatening issues such as spinal cord compression.

What are the possible side effects of nilutamide?

Multiple clinical trials evaluated the safety and efficacy of nilutamide. Possible side effects of nilutamide include hot flashes, delayed vision adjustment to darkness, breast pain or enlargement, nausea, diarrhea, swelling, constipation, and headache. These are not all the possible side effects of nilutamide. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with nilutamide.

Things to note about nilutamide

Less common but more serious side effects can accompany nilutamide including problems with your liver. Individuals should be closely monitored for signs of these serious side effects, and blood tests to assess liver function should be performed regularly. Patients should take their medication as prescribed by their doctor. Patients should talk to their doctor if they have any questions, or if they have questions regarding their nilutamide regimen. Alert your provider immediately if you notice any of the following symptoms:

  • Nausea and vomiting
  • Stomach or abdominal pain
  • Flu-like symptoms like soreness or muscle aches
  • Fatigue
  • Brown urine
  • Yellowing of the skin or whites of eyes (jaundice)
  • Loss of appetite
  • Inability to urinate

Additionally, although rare, there is a chance of developing interstitial pneumonitis, also called interstitial lung disease, while on nilutamide. Your provider will monitor you for signs of interstitial pneumonitis, however, you should alert them immediately if you notice any of the following:

  • Difficulty breathing
  • Coughing
  • Chest pain
  • Fever

Before starting nilutamide talk to your provider if you:

  • Have any liver, heart, kidney, or lung problems
  • Are taking any blood thinners
  • Have a partner who is pregnant or could become pregnant
  • Have any other medical conditions
  • Are currently taking any other medications (prescription and over-the-counter), vitamins, or herbal supplements

You should also contact your provider if you notice any signs of an allergic reaction to the medication, including chest pain or difficulty breathing. It is also important to consult the prescribing information for any other medications taken with nilutamide.

Receiving nilutamide

Nilutamide is administered orally and treatment is commonly started immediately after castration surgery. Your provider will determine the appropriate dosage and administration schedule for you, as well as the appropriate dosage and administration of any other medications taken with nilutamide. It is important to follow this schedule exactly as instructed, and not to stop taking nilutamide or any accompanying medications on your own.1

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